CNS LymphomaNCT01319591
Comparison of Creatinine Clearance Calculation for Estimation of GFR in Patients Receiving HD Methotrexate
An observational study of CNS Lymphoma and CNS Involvement of Systemic Lymphoma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The purpose of this study is to compare different estimates of calculating creatinine clearance by mathematical formula and compare them to creatinine clearance based on a timed urine collection in patients who received high-dose methotrexate for the treatment of primary CNS lymphoma or CNS involvement of systemic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CNS Lymphoma, CNS Involvement of Systemic Lymphoma
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to 1 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving high-dose methotrexate therapy at Dana-Farber Cancer Institute/Brigham and Women's Hospital
Who may be able to join
- Age >/= 18 years
- Received high-dose methotrexate therapy at Dana-Farber Cancer Institute/Brigham and Women's Hospital for the treatment of primary CNS lymphoma or CNS involvement of systemic lymphoma
- Available timed urine collection within 1 week of HDMTX
Who cannot join
- Receiving high-dose methotrexate for indications other than primary CNS lymphoma or CNS involvement of systemic lymphoma
- Documented viral hepatitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Comparison of Creatinine Clearance Calculation Methods for Estimation of Glomerular Filtration Rate in Patients Receiving High-Dose Methotrexate
The purpose of this study is to compare different estimates of calculating creatinine clearance by mathematical formula and compare them to creatinine clearance based on a timed urine collection in patients who received high-dose methotrexate for the treatment of primary CNS lymphoma or CNS involvement of systemic lymphoma.
Read the detailed description
We intend to perform a retrospective chart review to identify a serum creatinine-based equation that gives the best estimate of CrCl as compared with an equation derived from a 24-hour urine collection.
Study subjects will be identified using the Brigham and Women's Hospital and Dana-Farber Cancer Institute's Adult Pharmacy systems to identify patients who received high-dose methotrexate. Data will be collected starting with December 31, 2010 and proceeding chronologically backwards until the target enrollment of 40 patients is reached.
- Conditions
- CNS Lymphoma, CNS Involvement of Systemic Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CNS lymphoma patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify a serum creatinine-based equation that gives the best estimate of CrCl as compared to a measured creatinine clearance formula.
Serum creatinine-based equations to be included in that analysis are: Cockcroft-Gault with the following weight descriptors; ideal body weight, actual body weight, and adjusted body weight; Modified MDRD; CKD-EPI.
Measured: 1 year
Secondary outcomes (1)
To further compare each formula in a different subset of patients.
To further compare each formula in a different subset of patients: Age < 65 years and >/= 65 years; body mass index < 25, 25-30, 30-35, and > 35; serum creatinine <1.5 mg/dL and >/= 1.5 mg/dL.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2014
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS LymphomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Audrea Szabatura, Dana-Farber Cancer Institute
- Investigators
- Audrea H Szabatura, PharmD, BCOP, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319591
- Sponsor's protocol ID
- 11-043
- Status last verified
- Jan 2019
- First submitted
- 18 Mar 2011
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Creatinine Clearance Calculation Methods for Estimation of Glomerular Filtration Rate in Patients Receiving High-Dose Methotrexate
- ClinicalTrials.gov ID
- NCT01319591
- Acronym / sponsor ID
- 11-043
- Conditions
- CNS Lymphoma, CNS Involvement of Systemic Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 21 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare different estimates of calculating creatinine clearance by mathematical formula and compare them to creatinine clearance based on a timed urine collection in patients who received high-dose methotrexate for the treatment of primary CNS lymphoma or CNS involvement of systemic lymphoma.
Detailed description
We intend to perform a retrospective chart review to identify a serum creatinine-based equation that gives the best estimate of CrCl as compared with an equation derived from a 24-hour urine collection.
Study subjects will be identified using the Brigham and Women's Hospital and Dana-Farber Cancer Institute's Adult Pharmacy systems to identify patients who received high-dose methotrexate. Data will be collected starting with December 31, 2010 and proceeding chronologically backwards until the target enrollment of 40 patients is reached.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CNS lymphoma patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving high-dose methotrexate therapy at Dana-Farber Cancer Institute/Brigham and Women's Hospital
Key inclusion criteria (3 listed)
- Age >/= 18 years
- Received high-dose methotrexate therapy at Dana-Farber Cancer Institute/Brigham and Women's Hospital for the treatment of primary CNS lymphoma or CNS involvement of systemic lymphoma
- Available timed urine collection within 1 week of HDMTX
Key exclusion criteria (2 listed)
- Receiving high-dose methotrexate for indications other than primary CNS lymphoma or CNS involvement of systemic lymphoma
- Documented viral hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify a serum creatinine-based equation that gives the best estimate of CrCl as compared to a measured creatinine clearance formula.
Time frame: 1 year
Serum creatinine-based equations to be included in that analysis are: Cockcroft-Gault with the following weight descriptors; ideal body weight, actual body weight, and adjusted body weight; Modified MDRD; CKD-EPI.
1 secondary outcome
To further compare each formula in a different subset of patients.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrea H Szabatura, PharmD, BCOP principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CNS Lymphoma and CNS Involvement of Systemic Lymphoma, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify a serum creatinine-based equation that gives the best estimate of CrCl as compared to a measured creatinine clearance formula. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.